'World changer': Ghana first to approve Oxford malaria vaccine with 77 percent efficacy
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Ghana has become the first country to approve and clear a new malaria vaccine — called R21 — described as a "world-changer" by the scientists who developed it.
The R21/Matrix-M vaccine has been approved for use in children aged five to 36 months, the group at the highest risk of death from the malaria parasite, which is spread by mosquitoes. The vaccine is the first to exceed the World Health Organization's target of 75 percent efficacy and has demonstrated high levels of safety in Phase II trials.
"This marks a culmination of 30 years of malaria vaccine research at Oxford with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most," Professor Adrian Hill, Chief investigator, R21/Matrix-M program, and Director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine, said in a statement.
Need of the hour
According to last year's World Malaria Report, there were an estimated 619 000 malaria deaths globally in 2021 compared to 625 000 in the first year of the pandemic. According to the WHO, malaria is both endemic and perennial throughout Ghana. In 2021, WHO estimated an estimated 5,3 million malaria cases, with 12,500 estimated deaths recorded.
The low-dose vaccine, manufactured at a mass scale, can quickly be supplied to tropical countries at risk of the disease.
Initially designed and developed at the University of Oxford, the R21/Matrix-M has undergone trials in several countries, including an ongoing phase III trial in Burkina Faso, Kenya, Mali, and Tanzania that has enrolled 4,800 children. The release stated that results from these trials are expected to be reported later this year.
What's in the vaccine?
The vaccine contains Novavax’s (Nasdaq: NVAX) Matrix-M, a "saponin-based adjuvant that enhances the immune system response," making it more potent and durable.
Antigen-presenting cells are stimulated at the injection site by the Matrix-M adjuvant, enhancing antigen presentation in local lymph nodes.
"We expect R21 to make a major impact on malaria mortality in children in the coming years, and in the longer term [it] will contribute to overall final goal of malaria eradication and elimination," Prof Hill told the BBC.
The biotech giant Serum Institute of India is preparing to produce between 100-200 million doses per year, with a vaccine factory being constructed in Accra, Ghana.
"Developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult," Adar Poonawalla, CEO of the Serum Institute of India Pvt Ltd., said. "The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world," he added.
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